ComPAS Low-WAZ RCT Mali

Underweight Clinical Trial

Official title:

Simplified Treatment of Children With Low WAZ in Mali. A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05248516
• Other study ID #: H 1.00.033
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: September 1, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: January 2024
• Source: International Rescue Committee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Admissions criteria which treat children with only low mid-upper arm circumference (MUAC) or children with low weight-for-height z-score (WHZ) are not aligned with the evidence on which children are at risk of mortality. An analysis of community-based cohort data from Senegal found that a combination of weight-for-age z-score (WAZ) and MUAC criteria identified all children at risk of near-term death associated with severe anthropometric deficits. This finding has led to the suggestion that WAZ<-3 could be added as an independent admissions criterion for therapeutic feeding programs currently admitting children with MUAC<125 mm. However, there is little evidence to inform the debate about whether children with MUAC ≥125 mm and WAZ<-3 would benefit from treatment and, if so, what treatment protocol should be used.

This study will address whether children with WAZ <-3 but MUAC ≥125 mm benefit from therapeutic feeding and whether a simplified protocol is at least as effective as the more complicated weight-based standard protocol for this population.

The study will be a prospective, multi-center, individually randomized controlled trial (RCT). Children aged 6-59 months presenting with MUAC ≥125 mm and WAZ<-3 will be randomized to one of three study arms.

The primary objective of this study is to assess whether therapeutic feeding with a simplified protocol (1 sachet RUTF/day) results in superior nutritional outcomes compared to no therapeutic feeding AND non-inferior nutritional outcomes compared to the WHZ and weight based dosing regimen currently used in CMAM treatment 2 months after diagnosis among children aged 6-59 months with MUAC ≥125 mm and WAZ<-3 .

The primary outcome is the mean WAZ of children. Secondary outcomes include a) proportion of children with WAZ <-3, b) mean MUAC of children, c) proportion of children with MUAC < 125 mm, d) mean WHZ, mean HAZ, e) proportion of children with WHZ<-3 or HAZ<-3, f) change in WAZ, MUAC, WHZ, HAZ from enrolment to endpoint g) mean skinfold thickness measure.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: April 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

Inclusion Criteria:

• Age between 6 and 59 months

• MUAC =125 mm

• WAZ <-3

• Living in the study catchment area

• Expects to be able to continue follow-up visits for next 6 months

Exclusion Criteria:

• nutritional edema

• Known peanut or milk allergy

• Severe illnesses requiring inpatient level treatment (according to IMCI guidelines)

• Medical condition affecting food intake (lip and palate cleft, handicap etc.)

• Has already taken part in the study

Related Conditions & MeSH terms

• Malnutrition
• Thinness
• Underweight

Intervention

Dietary Supplement:
• Simplified dose of ready-to-use therapeutic food (RUTF)
In the simplified arm all children receive the same dose: 1 sachet of RUTF/day. This until discharge from treatment. Recovery from treatment will be defined as WAZ>= -3 on 2 consecutive visits. A maximum of 12 treatment weeks are allowed before declaring non-response. Defaulting will be declared after 2 consecutively missed visits.
• Standard dose of ready-to-use therapeutic food (RUTF)
In the standard arm, children will receive different doses of RUTF depending on their WHZ category and weight. children with a WHZ<-3 will receive the equivalent of 200kcal/kg/d of RUTF until discharge. children with a WHZ between -3 and -2 will receive 1 sachet (500kcal) of RUTF per day until discharge. children with a WHZ>=-2 will receive no nutritional treatment. Recovery from treatment will be defined as WHZ>= -2 on 2 consecutive visits. A maximum of 12 treatment weeks are allowed before declaring non-response. Defaulting will be declared after 2 consecutively missed visits.
• No nutritional treatment
no nutritional treatment will be provided to children in the control arm.

Locations

Country	Name	City	State
Mali	Dilly	Nara	Koulikoro
Mali	Gassambarou	Nara	Koulikoro
Mali	Goumbou	Nara	Koulikoro
Mali	Kaloumba	Nara	Koulikoro
Mali	Karfabougou	Nara	Koulikoro
Mali	Koira	Nara	Koulikoro
Mali	Koronga	Nara	Koulikoro
Mali	Madina-Kagoro	Nara	Koulikoro
Mali	Nara Central	Nara	Koulikoro
Mali	Sampaga	Nara	Koulikoro
Mali	Tiapato	Nara	Koulikoro

Sponsors (3)

Lead Sponsor	Collaborator
International Rescue Committee	Ministry of health, Mali, University of the Sciences, Techniques and Technologies of Bamako

Country where clinical trial is conducted

Mali, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	subscapular skin-fold thickness in millimeters	this outcome is a continuous outcome. there are currently no internationally accepted standards for the skinfold measure of young children. we will thus report the mean and any other relevant data on this and discuss the results in light of past research.	2 and 6 months post-enrolment
Other	proportion having developed a mid-upper-arm circumference <125mm	the proportion of children that exit the study with a MUAC<125mm at any point in time will be estimated. MUAC will be measured at each visit using a while MUAC tape with a precision of 1mm.	6 months post-enrolment
Other	tricep skin-fold thickness in millimeters	this outcome is a continuous outcome. there are currently no internationally accepted standards for the skinfold measure of young children. we will thus report the mean and any other relevant data on this and discuss the results in light of past research.	2 and 6 months post-enrolment
Other	fat-free mass in kg	this outcome is a continuous outcome obtained through bioelectrical impedance analysis and applying a suitable equation to obtain fat-free mass estimations from weight and impedance.	2 and 6 months post-enrolment
Other	fat mass in kg	this outcome is a continuous outcome obtained through bioelectrical impedance analysis and applying a suitable equation to first obtain fat-free mass estimations from weight and impedance and then by substracting fat-free mass from weight.	2 and 6 months post-enrolment
Other	fat-free mass index in kg/m2	this outcome is a continuous outcome obtained through bioelectrical impedance analysis and applying a suitable equation to obtain fat-free mass estimations from weight and impedance and indexing fat-free mass to height squared to adjust for differences in size.	2 and 6 months post-enrolment
Other	fat mass index in kg/m2	this outcome is a continuous outcome obtained through bioelectrical impedance analysis and applying a suitable equation to first obtain fat-free mass estimations from impedance and weight and then substracting fat-free mass from weight and indexing the obtained fat mass to height squared to adjust for differences in size.	2 and 6 months post-enrolment
Other	hemoglobin (g/l)	this is a continuous outcome and will be obtained through HemoCue measurement of peripheral blood	2 and 6 months
Other	anaemia	this is a binary outcome and will be obtained through hemoglobin measurement of peripheral blood and categorising Hb<11g/l as anaemic.	2 and 6 months
Primary	weight-for-age z-score (WAZ)	the primary outcome is a continuous outcome: a higher WAZ indicates of a positive outcome. To construct WAZ at any point in time, children's age will be calculated based on their age at admission and their weight will be measured at each time point with 0.1kg precision. WAZ will be calculated using zscore06 fonction in STATA that is based on the WHO growth reference data specific to each gender.	2 months after enrolment
Secondary	weight-for-age z-score (WAZ)	the secondary outcome is a continuous outcome: a higher WAZ indicates a positive outcome. To construct WAZ at any point in time, children's age will be calculated based on their age at admission and their weight will be measured at each time point with 0.1kg precision. WAZ will be calculated using zscore06 fonction in STATA that is based on the WHO growth reference data specific to each gender.	6 months after enrolment
Secondary	weight-for-age z-score (WAZ) <-3	this outcome is binary: a higher proportion of WAZ<-3 indicates a negative outcome. To construct WAZ at any point in time, children's age will be calculated based on their age at admission and their weight will be measured at each time point with 0.1kg precision. WAZ will be calculated using zscore06 fonction in STATA that is based on the WHO growth reference data specific to each gender.	both at 2 and 6 months post-enrolment
Secondary	weight-for-height z-score (WHZ)	this outcome is a continuous outcome: a higher WHZ indicates a positive outcome. To construct WHZ at any point in time, children's height and weight will be measured at each time point: height with 0.1cm precision and weight with 0.1kg precision. WHZ will be calculated using zscore06 fonction in STATA that is based on the WHO growth reference data specific to each gender.	both at 2 and 6 months post-enrolment
Secondary	weight-for-height z-score (WHZ) <-3	this outcome is binary: a higher proportion of WHZ<-3 indicates a negative outcome. To construct WHZ at any point in time, children's height and weight will be measured at each time point: height with 0.1cm precision and weight with 0.1kg precision. WHZ will be calculated using zscore06 fonction in STATA that is based on the WHO growth reference data specific to each gender.	both at 2 and 6 months post-enrolment
Secondary	height-for-age z-score (HAZ)	this outcome is a continuous outcome: a higher HAZ indicates a positive outcome. To construct HAZ at any point in time, children's age will be calculated based on their age at admission and their height will be measured at each time point with 0.1cm precision. HAZ will be calculated using zscore06 fonction in STATA that is based on the WHO growth reference data specific to each gender.	both at 2 and 6 months post-enrolment
Secondary	height-for-age z-score (HAZ) <-3	this outcome is binary: a higher proportion of HAZ<-3 indicates a negative outcome. To construct HAZ at any point in time, children's age will be calculated based on their age at admission and their height will be measured at each time point with 0.1cm precision. HAZ will be calculated using zscore06 fonction in STATA that is based on the WHO growth reference data specific to each gender.	both at 2 and 6 months post-enrolment
Secondary	Mid-upper-arm circumference (MUAC)	this outcome is a continuous outcome: a higher MUAC indicates a positive outcome. MUAC will be measured using a while MUAC tape with a precision of 1mm.	both at 2 and 6 months post-enrolment